EMEA-001540-PIP01-13-M01
Key facts
| Active substance |
Recombinant human beta-glucuronidase (rhGUS, UX003)
|
| Therapeutic area |
Endocrinology-Gynaecology-Fertility-Metabolism
|
| Decision number |
P/0202/2016
|
| PIP number |
EMEA-001540-PIP01-13-M01
|
| Pharmaceutical form(s) |
Solution for injection/infusion
|
| Condition(s) / indication(s) |
Treatment of Mucopolysaccharidosis type VII
|
| Route(s) of administration |
Intravenous use
|
| Contact for public enquiries |
Ultragenyx Germany GmbH
E-mail: medinfo@ultragenyx.com |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|
| Compliance procedure number |
EMEA-C-001540-PIP01-13-M01
|
| Compliance opinion date |
11/12/2019
|
| Compliance outcome |
positive
|